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Surgical resection alone is regarded as the standard of care for patients with liver metastases from colorectal cancer, but relapse is common. We assessed the combination of perioperative chemotherapy and surgery compared with surgery alone for patients with initially resectable liver metastases from colorectal cancer. This parallel-group study reports the trial's final data for progression-free survival for a protocol unspecified interim time-point, while overall survival is still being monitored. 364 patients with histologically proven colorectal cancer and up to four liver metastases were randomly assigned to either six cycles of FOLFOX4 before and six cycles after surgery or to surgery alone (182 in perioperative chemotherapy group vs 182 in surgery group). Patients were centrally randomised by minimisation, adjusting for centre and risk score. The primary objective was to detect a hazard ratio (HR) of 0·71 or less for progression-free survival. Primary analysis was by intention to treat. Analyses were repeated for all eligible (171 vs 171) and resected patients (151 vs 152). This trial is registered with ClinicalTrials.gov, number NCT00006479. In the perioperative chemotherapy group, 151 (83%) patients were resected after a median of six (range 1–6) preoperative cycles and 115 (63%) patients received a median six (1–8) postoperative cycles. 152 (84%) patients were resected in the surgery group. The absolute increase in rate of progression-free survival at 3 years was 7·3% (from 28·1% [95·66% CI 21·3–35·5] to 35·4% [28·1–42·7]; HR 0·79 [0·62–1·02]; p=0·058) in randomised patients; 8·1% (from 28·1% [21·2–36·6] to 36·2% [28·7–43·8]; HR 0·77 [0·60–1·00]; p=0·041) in eligible patients; and 9·2% (from 33·2% [25·3–41·2] to 42·4% [34·0–50·5]; HR 0·73 [0·55–0·97]; p=0·025) in patients undergoing resection. 139 patients died (64 in perioperative chemotherapy group vs 75 in surgery group). Reversible postoperative complications occurred more often after chemotherapy than after surgery (40/159 [25%] vs 27/170 [16%]; p=0·04). After surgery we recorded two deaths in the surgery alone group and one in the perioperative chemotherapy group. Perioperative chemotherapy with FOLFOX4 is compatible with major liver surgery and reduces the risk of events of progression-free survival in eligible and resected patients. Swedish Cancer Society, Cancer Research UK, Ligue Nationale Contre le Cancer, US National Cancer Institute, Sanofi-Aventis.

In resectable gastric and gastroesophageal junction cancer, adding durvalumab to perioperative chemotherapy improved event-free survival and pathological complete response, with no major increase in high-grade adverse events.

The best multimodal approach for resectable locally advanced esophageal adenocarcinoma is unclear. An important question is whether perioperative chemotherapy is preferable to preoperative chemoradiotherapy. In this phase 3, multicenter, randomized trial, we assigned in a 1:1 ratio patients with resectable esophageal adenocarcinoma to receive perioperative chemotherapy with FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) plus surgery or preoperative chemoradiotherapy (radiotherapy at a dose of 41.4 Gy and carboplatin and paclitaxel) plus surgery. Eligibility criteria included a primary tumor with a clinical stage of cT1 cN+, cT2-4a cN+, or cT2-4a cN0 disease, in which T indicates the size and extent of the tumor (higher numbers indicate a more advanced tumor), and N indicates the presence (N+) or absence (N0) of cancer spread to the lymph nodes, without evidence of metastatic spread. The primary end point was overall survival. From February 2016 through April 2020, we assigned 221 patients to the FLOT group and 217 patients to the preoperative-chemoradiotherapy group. With a median follow-up of 55 months, overall survival at 3 years was 57.4% (95% confidence interval [CI], 50.1 to 64.0) in the FLOT group and 50.7% (95% CI, 43.5 to 57.5) in the preoperative-chemoradiotherapy group (hazard ratio for death, 0.70; 95% CI, 0.53 to 0.92; P = 0.01). Progression-free survival at 3 years was 51.6% (95% CI, 44.3 to 58.4) in the FLOT group and 35.0% (95% CI, 28.4 to 41.7) in the preoperative-chemoradiotherapy group (hazard ratio for disease progression or death, 0.66; 95% CI, 0.51 to 0.85). Among the patients who started the assigned treatment, grade 3 or higher adverse events were observed in 120 of 207 patients (58.0%) in the FLOT group and in 98 of 196 patients (50.0%) in the preoperative-chemoradiotherapy group. Serious adverse events were observed in 98 of 207 patients (47.3%) in the FLOT group and in 82 of 196 patients (41.8%) in the preoperative-chemoradiotherapy group. Mortality at 90 days after surgery was 3.1% in the FLOT group and 5.6% in the preoperative-chemoradiotherapy group. Perioperative chemotherapy with FLOT led to improved survival among patients with resectable esophageal adenocarcinoma as compared with preoperative chemoradiotherapy. (Funded by the German Research Foundation; ESOPEC ClinicalTrials.gov number, NCT02509286.).

Abstract Objective To assess whether perioperative management guided by near-infrared spectroscopy to determine tissue oxygen saturation and haemodynamic monitoring reduces postoperative complications after off-pump coronary artery bypass grafting. Design Assessor blinded, single centre, randomised controlled trial (Bottomline-CS trial). Setting A tertiary teaching hospital in China. Participants 1960 patients aged 60 years or older who were scheduled for elective off-pump coronary artery bypass grafting. Interventions All patients had multisite monitoring of tissue oxygen saturation (bilateral forehead and unilateral forearm brachioradialis) and haemodynamic monitoring. Both groups received usual care, including arterial blood pressure, central venous pressure, electrocardiography, and transoesophageal echocardiography when indicated. Guided care aimed to maintain tissue oxygenation within 10% above or below preoperative baseline values, established 24-48 hours before surgery, from the start of anaesthesia until extubation or for up to 24 hours postoperatively. In the usual care group, tissue oximetry and haemodynamic data were concealed, and care was routine. Main outcome measures The primary outcome was the incidence of a composite of 30 day postoperative complications, which were cerebral, cardiac, respiratory, renal, infectious, and mortality complications. Secondary outcomes included the individual components of the composite outcome, new-onset atrial fibrillation, and hospital length of stay. Results Of 1960 patients randomly assigned, data from 967 guided care and 974 usual care patients were analysed. During anaesthesia, the area under the curve for tissue oxygen saturation measurements outside the plus and minus 10% baseline range was significantly smaller with guided care than only usual care: left forehead 32.4 versus 57.6 (%×min, P<0.001), right forehead 37.9 versus 62.6 (P<0.001), and forearm 14.8 versus 44.7 (P<0.001). The primary composite outcome occurred in 457/967 (47.3%) patients in the guided care group and 466/974 (47.8%) patients in the usual care group (unadjusted risk ratio 0.99 (95% confidence interval 0.90 to 1.08), P=0.83). No secondary outcomes differed significantly between groups. The largest observed difference was in incidence of pneumonia, which was less frequent in the guided care group (88/967, 9.1%) than in the usual care group (121/974, 12.4%) and not statistically significant after adjusting for multiple comparisons. Conclusions Guided care by use of multisite near-infrared spectroscopy and haemodynamic monitoring effectively maintained tissue oxygenation near baseline levels compared with usual care. However, no clear evidence was noted that this approach reduced the incidence of major postoperative complications. These findings do not support the routine use of near-infrared spectroscopy and haemodynamic monitoring to maintain tissue oxygenation during off-pump coronary artery bypass grafting. Trial registration ClinicalTrials.gov NCT04896736.

Patients undergoing surgery often experience stress and anxiety, which can increase complications and hinder recovery. Effective management of these psychological factors is key to improving outcomes. Preoperative anxiety is inversely correlated with the amount of information patients receive, but accessible, personalized support remains limited, especially in preoperative settings. Face-to-face education is often impractical due to resource constraints. Digital health (DH) interventions offer a promising alternative, enhancing patient engagement and empowerment. However, most current tools focus on providing information, overlooking the importance of personalization and psychological support. This study aimed to assess the viability of a DH intervention known as the Adhera CARINAE DH Program. This program is specifically designed to offer evidence-based and personalized stress- and anxiety-management techniques. It achieves this by using a comprehensive digital ecosystem that incorporates wearable devices, mobile apps, and virtual reality technologies. The intervention program also makes use of advanced data-driven techniques to deliver tailored patient education and lifestyle support. A total of 74 patients scheduled for surgery across 4 hospitals in 3 European countries were enrolled in this study from September 2021 to March 2022. Surgeries included cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacements, prostate or bladder cancer surgeries, hip and knee replacements, maxillofacial surgery, and scoliosis procedures. After assessment for eligibility, participants were randomized into 2 groups: the intervention group (n=23) received the Adhera CARINAE DH intervention in addition to standard care, while the control group (n=27) received standard care alone. Psychological metrics such as self-efficacy, self-management, and mental well-being were assessed before and after the intervention, alongside physiological markers of stress. The intervention group demonstrated significant improvements across several psychological outcomes. For example, Visual Analogue Scale Stress at the hospital improved at admission by 5% and at hospital discharge by 11.1% and Visual Analogue Scale Pain at admission improved by 31.2%. In addition, Hospital Anxiety and Depression Scale Anxiety after surgery improved by 15.6%, and Positive and Negative Affect Scale-Negative at hospital admission improved by 17.5%. Overall, patients in the intervention study spent 17.12% less days in the hospital. Besides these individual scores, the intervention group shows more positive relationships among the psychological dimensions of self-efficacy, self-management, and mental well-being, suggesting that the CARINAE solution could have a positive effect and impact on the reduction of stress and negative emotions. Our results provide an important first step toward a deeper understanding of optimizing DH solutions to support patients undergoing surgery and for potential applications in remote patient monitoring and communication. ClinicalTrials.gov NCT05184725; https://clinicaltrials.gov/study/NCT05184725. RR2-10.2196/38536.

To mitigate perioperative hypothermia, patients can be warmed preoperatively and intraoperatively with forced-air warming (FAW) and conductive warming (CW) methods. We examined the association of four combinations of pre- and intraoperative CW and FAW with the magnitude of intraoperative hypothermia. We conducted a prospective randomized trial at a tertiary healthcare center in the United States (trial registration number ISRCTN23065394). Patients were randomized to 4 arms based on the following pre/intraoperative warming combinations: (1) CW/CW, (2) FAW/FAW, (3) no active prewarming (NAPW)/CW, (4) NAPW/FAW. Body temperature was measured using an esophageal probe. The area under the temperature curve (AUC) below 36°C was calculated according to the trapezoidal rule and quantified intraoperative hypothermia. A mixed model was used to estimate differences in AUC between the 4 arms. 182 patients were analyzed. Patients in the NAPW/FAW arm had the highest AUC values while those in the CW/CW arm had the lowest. AUC values [median (Q1, Q3] were as follows: CW/CW = 4.7 (0, 26.6); FAW/FAW = 8.0 (0, 30.8); NAPW/CW = 7.4 (0, 27.1); NAPW/FAW = 19.9 (5.0, 44.3). Mixed model results showed significant lower AUC values in CW/CW and NAPW/CW when compared to NAPW/FAW. The ratio of mean AUC [95% CI] between CW/CW vs NAPW/FAW was 0.49 [0.24, 0.98], 51% lower, and between NAPW/CW and NAPW/FAW, 0.46 [0.23, 0.91], 54% lower. When the AUC was normalized to the duration of surgery (AUC/case duration in°C, or \"relative AUC\"), significant lower relative AUC values were observed between FAW/FAW vs NAPW/FAW (48% lower, p = 0.0419) and NAPW/CW vs NAPW/FAW (48% lower, p = 0.0407). CW is more effective than FAW at reducing intraoperative hypothermia when FAW is used without prewarming. When patients are actively prewarmed, CW and FAW show no difference in their ability to maintain patient temperature.

Trials of β blockers in patients undergoing non-cardiac surgery have reported conflicting results. This randomised controlled trial, done in 190 hospitals in 23 countries, was designed to investigate the effects of perioperative β blockers. We randomly assigned 8351 patients with, or at risk of, atherosclerotic disease who were undergoing non-cardiac surgery to receive extended-release metoprolol succinate (n=4174) or placebo (n=4177), by a computerised randomisation phone service. Study treatment was started 2–4 h before surgery and continued for 30 days. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal cardiac arrest. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00182039. All 8351 patients were included in analyses; 8331 (99·8%) patients completed the 30-day follow-up. Fewer patients in the metoprolol group than in the placebo group reached the primary endpoint (244 [5·8%] patients in the metoprolol group vs 290 [6·9%] in the placebo group; hazard ratio 0·84, 95% CI 0·70–0·99; p=0·0399). Fewer patients in the metoprolol group than in the placebo group had a myocardial infarction (176 [4·2%] vs 239 [5·7%] patients; 0·73, 0·60–0·89; p=0·0017). However, there were more deaths in the metoprolol group than in the placebo group (129 [3·1%] vs 97 [2·3%] patients; 1·33, 1·03–1·74; p=0·0317). More patients in the metoprolol group than in the placebo group had a stroke (41 [1·0%] vs 19 [0·5%] patients; 2·17, 1·26–3·74; p=0·0053). Our results highlight the risk in assuming a perioperative β-blocker regimen has benefit without substantial harm, and the importance and need for large randomised trials in the perioperative setting. Patients are unlikely to accept the risks associated with perioperative extended-release metoprolol. Canadian Institutes of Health Research; Commonwealth Government of Australia's National Health and Medical Research Council; Instituto de Salud Carlos III (Ministerio de Sanidad y Consumo), Spain; British Heart Foundation; AstraZeneca.

Background The aim of this trial was to compare the Enhanced Recovery After Surgery (ERAS) program with conventional perioperative management in patients who underwent radical resection for colorectal cancer. Methods A combination of evidence-based and consensus methodology was used to develop the ERAS protocol. Five hundred ninety-seven consecutive patients who underwent elective colorectal resection were randomized to either the ERAS ( n  = 299) or the control group ( n  = 298). Outcomes relating to nutrition and metabolism index, stress index, and recovery index were measured and recorded. Results Demographic and operative data were similar between the two groups. Patients in the ERAS group showed improved nutritional status when compared with those of the control group. On postoperative day (POD) 1, the HOMA-IR (insulin resistance index) of the ERAS group was lower than that of the control group ( p  < 0.001). The cortisol level of the control group was elevated on both POD 1 ( p  = 0.007) and POD 5 ( p  = 0.002) compared to the preoperative level. However, the cortisol level of the ERAS group was not increased until POD 5 ( p  = 0.001). Reduced levels of TNF-α, IL-1β, IL-6, and IFN-γ in the ERAS group indicated less postoperative stress responses. In addition, ERAS was associated with accelerated recovery of gastrointestinal function. The postoperative length of stay ( p  < 0.001) and expense ( p  < 0.001) for the ERAS group were reduced in comparison to the controls. Twenty-eight cases in the control group and twenty-nine in the ERAS group suffered complications, which was not significantly different. Conclusion The ERAS protocol attenuates the surgical stress response and accelerates postoperative recovery without compromising patient safety.

Purpose As global initiatives increase patient access to surgical treatments, there is a need to define optimal levels of perioperative care. Our aim was to describe the relationship between the provision and use of critical care resources and postoperative mortality. Methods Planned analysis of data collected during an international 7-day cohort study of adults undergoing elective in-patient surgery. We used risk-adjusted mixed-effects logistic regression models to evaluate the association between admission to critical care immediately after surgery and in-hospital mortality. We evaluated hospital-level associations between mortality and critical care admission immediately after surgery, critical care admission to treat life-threatening complications, and hospital provision of critical care beds. We evaluated the effect of national income using interaction tests. Results 44,814 patients from 474 hospitals in 27 countries were available for analysis. Death was more frequent amongst patients admitted directly to critical care after surgery (critical care: 103/4317 patients [2%], standard ward: 99/39,566 patients [0.3%]; adjusted OR 3.01 [2.10–5.21]; p  < 0.001). This association may differ with national income (high income countries OR 2.50 vs. low and middle income countries OR 4.68; p  = 0.07). At hospital level, there was no association between mortality and critical care admission directly after surgery ( p  = 0.26), critical care admission to treat complications ( p  = 0.33), or provision of critical care beds ( p  = 0.70). Findings of the hospital-level analyses were not affected by national income status. A sensitivity analysis including only high-risk patients yielded similar findings. Conclusions We did not identify any survival benefit from critical care admission following surgery.

Background Practices such as prolonged preoperative fasting, bowel preparation, delayed ambulation and resumption of orals result in morbidity in 15-20% of stoma reversal cases which can be improved by Enhanced Recovery After Surgery (ERAS) pathways. Aim To evaluate the safety, feasibility and efficacy of ERAS pathway in patients undergoing elective loop ileostomy or colostomy reversal surgery Methods This was an open-labeled, superiority randomized controlled trial in which patients undergoing loop ileostomy or colostomy reversal were randomized to standard or ERAS care. Patients with ASA class ≥3, needing laparotomy for stoma reversal, cardiac, renal and neurological illnesses were excluded. Components of ERAS protocol included pre-operative carbohydrate loading, avoidance of mechanical bowel preparation, goal directed fluid therapy, avoidance of long-acting opioid anesthetics or analgesics, avoidance of drains, urinary catheter or nasogastric tube, early mobilization and early enteral feeding. The primary outcome was length of stay (LOS) while the secondary outcomes were postoperative recovery and morbidity parameters. Results Forty patients each were randomized to standard care and ERAS. Demographic and laboratory parameters between the two groups were comparable. ERAS group patients had significantly reduced LOS (5.3 ± 0.3 vs 7 ± 2.6; mean difference: 1.73 ± 0.98; p=0.0008). Functional recovery was earlier in the ERAS group compared to the standard care group, such as early resolution of ileus (median-2 days; p<0.001), time to first stool (median-3 days; p=0.0002), time to the resumption of liquid diet (median-3 days; p<0.001) and solid diet (median-4 days; p<0.001). Surgical site infections (SSI) were significantly lesser in ERAS group (12.5% vs 32.5%; p=0.03) while postoperative nausea/vomiting (p=0.08), pulmonary complications (p=0.17) and urinary tract infections (p=0.56) were comparable in both groups. Conclusion ERAS pathways are feasible, safe and significantly reduces LOS in patients undergoing elective loop ileostomy or colostomy reversal surgery.